MAUDE Adverse Event Report: THE SPECTRANETICS CORPORATION SPECTRANETICS LEAD LOCKING DEVICE; STYLET, CATHETER

Model Number 518-039

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/02/2021

Event Type  Injury  

Manufacturer Narrative

Patient''s ethnicity and race unavailable.Device lot number, and expiration date unavailable.The device was discarded, thus no investigation could be completed.Device manufacture date unavailable because device lot number unavailable.

Event Description

A lead extraction procedure commenced to remove 4 leads: a right atrial (ra) lead, two right ventricular (rv) leads and one left ventricular (lv) lead due to cellulitis and cied system/pocket infection.Spectranetics lead locking devices (llds) were inserted into each lead to provide traction to aid in the leads'' extractions.The llds were able to advance all the way down to the distal tip of the two rv leads and the ra lead; however, the lld could only advance partway down the lv lead and was locked in placed at approximately the mid ra area.It was reported that the leads were heavily calcified and adhered together in the innominate/superior vena cava (svc) junction.The ra and both rv leads were successfully removed with use of a spectranetics 13f tightrail rotating dilator sheath.At no point were there any hemodynamic changes, nor any slack or visible changes of the lv lead while taking the others out.Attention was then turned to removing the lv lead.The 13f tightrail device was again used, but the lack of traction wouldn''t allow the tightrail to track over the lead past the point where the lld was locked in the lead.During this time, the suture and insulation broke on the lv lead, leaving nothing to grab on to.The physician decided to use a femoral approach and chose a cook medical needle''s eye snare to grab the lead.He used manual traction to try to remove the lead but mentioned that he felt resistance.While holding manual traction, the lead could be observed stretching at the ring.It continued stretching the ring and after several minutes, the physician was concerned the lead would break so he advanced the inner sheath of the needle¿s eye snare to the proximal portion of the ring at which point the lead released.He was able to remove the entire lv lead from the groin.However, immediately afterward, the patient''s blood pressure dropped.Rescue efforts began, including sternotomy.A tear in the coronary sinus was discovered, after use of the cook medical needle''s eye snare.This injury was successfully repaired and the patient survived the procedure.There was no alleged malfunction of any spectranetics device in use during the procedure.This report is being submitted to capture the lld which had been inserted partially down the lv lead and was providing the traction platform for the lv lead when the suture and insulation broke.

• Brand Name: SPECTRANETICS LEAD LOCKING DEVICE
• Type of Device: STYLET, CATHETER
• Manufacturer (Section D): THE SPECTRANETICS CORPORATION; 9965 federal drive; colorado springs CO 80921
• Manufacturer (Section G): THE SPECTRANETICS CORPORATION; 9965 federal drive; colorado springs CO 80921
• Manufacturer Contact: barbara creel ; 9965 federal drive; colorado springs, CO 80921
• MDR Report Key: 12061494
• MDR Text Key: 265164413
• Report Number: 1721279-2021-00118
• Device Sequence Number: 1
• Product Code: DRB
• UDI-Device Identifier: 00813132023058
• UDI-Public: 00813132023058
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: K043401
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/24/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 518-039
• Device Catalogue Number: 518-039
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/02/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 69 YR
• Patient Weight: 79